NCT04181437已完成1 期
A Phase I Clinical Trial to Evaluate the Pharmacokinetic Interaction and Safety Between NVP-1203-R1 and NVP-1203-R2 in Healthy Adult Subjects
NVP Healthcare1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年5月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pharmacokinetic interaction
研究概览
简要总结
The purpose of this study is to compare the pharmacokinetics and safety between NVP-1203-R1 and NVP-1203-R2
详细描述
pharmacokinetics and safety between NVP-1203-R1 and NVP-1203-R2
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy adult subjects who signed informed consent
排除标准
- •Subjects has a history of allergy reaction of study drug ingredient
- •Subjects participated in another clinical trial within 6 months prior to administration of the study drug
- •Inadequate subject for the clinical trial by the investigator's decision
研究组 & 干预措施
NVP-1203-R1 and NVP-1203-R2
Experimental
Drug: NVP-1203-R1 1 tablet and NVP-1203-R2 1 tablet co-administration(oral dosing)
干预措施: NVP-1203-R1 and NVP-1203-R2 (Drug)
NVP-1203-R1
Experimental
Drug: NVP-1203-R1
1 tablet, oral dosing
干预措施: NVP-1203-R1 (Drug)
NVP-1203-R2
Experimental
Drug: NVP-1203-R2
1 tablet, oral dosing
干预措施: NVP-1203-R2 (Drug)
结局指标
主要结局
Pharmacokinetic interaction
时间窗: 0hours - 24hours
Area under the curve (AUC)
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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